• Title/Summary/Keyword: Ruggedness

Search Result 70, Processing Time 0.022 seconds

Development and Validation of an HPLC Method for the Pharmacokinetic Study of Etodolac in Human (에토돌락 체내동태 연구를 위한 혈청 중 에토돌락의 HPLC 정량법 개발 및 검증)

  • Cho, Hea-Young;Kang, Hyun-Ah;Moon, Jai-Dong;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.35 no.4
    • /
    • pp.265-271
    • /
    • 2005
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of etodolac in human serum was developed, validated, and applied to the pharmacokinetic study of etodolac. Etodolac and internal standard, ibuprofen were extracted from human serum by liquid-liquid extraction with hexane/isopropanol (95:5, v/v) and analyzed on a Luna C18(2) column with the mobile phase of 1% aqueous acetic acid-acetonitrile (4:6, v/v). Detection wavelength of 227 nm and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^3$ factorial design using a fixed etodolac concentration $(1\;{\mu}g/mL)$ with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of $0.05-40\;{\mu}g/mL$ with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 0.05 ${\mu}g/mL$, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 92.00 to 110.00% for etodolac with overall precision (% C.V.) being 1.08-10.11%. The percent recovery for human serum was in the range of 76.73-115.30%. Stability studies showed that etodolac was stable during storage, or during the assay procedure in human serum. The peak area and retention time of etodolac were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of etodolac in human serum samples for the pharmacokinetic studies of orally administered Lodin XL tablet (400 mg as etodolac) at three different laboratories, demonstrating the suitability of the method.

Development and Validation of an HPLC Method for the Pharmacokinetic Study of Fenoprofen in Human (페노프로펜 체내동태 연구를 위한 혈청 중 페노프로펜의 HPLC 정량법 개발 및 검증)

  • Cho, Hye-Young;Kang, Hyun-Ah;Kim, Yoon-Gyoon;Sah, Hong-Kee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.35 no.6
    • /
    • pp.423-429
    • /
    • 2005
  • A selective and sensitive reversed-phase HPLC method for the determination of fenoprofen in human serum was developed, validated, and applied to the pharmacokinetic study of fenoprofen calcium. Fenoprofen and internal standard, ketoprofen, were extracted from human serum by liquid-liquid extraction with diethyl ether and analyzed on a Luna C18(2) column with the mobile phase of acetonitrile-3 mM potassium dihydrogen phosphate (32:68, v/v, adjusted to pH 6.6 with phosphoric acid). Detection wavelength of 272 nm and flow rate of 0.25 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed fenoprofen concentration $(2\;{\mu}g/mL)$ with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of $0.05-100\;{\mu}g/mL$ with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was $0.05\;{\mu}g/mL$, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 92.27 to 109.20% for fenoprofen with overall precision (% C.V.) being 5.51-11.71 %. The relative mean recovery of fenoprofen for human serum was 81.7%. Stability (freeze-thaw, short and long-term) studies showed that fenoprofen was not stable during storage. But, extracted serum sample and stock solution were allowed to stand at ambient temperature for 12 hr prior to injection without affecting the quantification. The peak area and retention time of fenoprofen were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of fenoprofen in human serum samples for the pharmacokinetic studies of orally administered Fenopron tablet (600 mg as fenoprofen) at three different laboratories, demonstrating the suitability of the method.

Validation of an LC/MS/MS Method for the Pharmacokinetic Study of Lercanidipine (염산레르카니디핀 체내동태 연구를 위한 혈청 중 레르카니디핀의 LC/MS/MS 정량법 검증)

  • Kim, Se-Mi;Kim, Hwan-Ho;Shin, Sae-Byeok;Kang, Hyun-Ah;Yoon, Hwa;Cho, Hea-Young;Kim, Yoon-Gyoon;Yang, Chan-Woo;Yong, Chul-Soon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.37 no.4
    • /
    • pp.223-227
    • /
    • 2007
  • A rapid, simple and sensitive LC/MS/MS method for the determination of lercanidipine in human serum was validated and applied to the pharmacokinetic study of lercanidipine. Lercanidipine and internal standard, amlodipine, were extracted from human serum by liquid-liquid extraction with hexan-isoamyl alcohol (100: 1, v/v) and analyzed on a $Symmetry^{(R)}$ MS $C_{18}$ column with the mobile phase of acetonitrile-0.2% aqueous formic acid (70: 30, v/v). Using MS/MS with multiple reaction monitoring (MRM) mode, lercanidipine and amlodipine were detected without severe interferences from human serum matrix. Lercanidipine produced a protonated precursor ion ($[M+H]^+$) at m/z 612.3 and a corresponding product ion at m/z 280.0. Internal standard produced a protonated precursor ion ($[M+H]^+$]) at m/z 409.0 and a corresponding product ion at m/z 238.0. The ruggedness of this method was investigated using quality control (QC) samples. This method showed linear response over the concentration range of 0.05-20 ng/mL with correlation coefficient greater than 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the developed method ranged from 85.51 to 112.2% for lercanidipine with overall precision (% C.V.) being 3.56-13.1%. This method showed good ruggedness (within 15% C.V.) and was successfully applied for the analysis of lercanidipine in human serum samples for the pharmacokinetic studies, demonstrating the suitability of the method.

Development and Validation of an HPLC Method for the Pharmacokinetic Study of Dipyridamole in Human (디피리다몰 체내동태 연구를 위한 혈청 중 디피리다몰의 HPLC 정량법 개발 및 검증)

  • Cho, Hea-Young;Kang, Hyun-Ah;Moon, Jae-Dong;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.36 no.1
    • /
    • pp.45-51
    • /
    • 2006
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of dipyridamole in human serum was developed, validated, and applied to the pharmacokinetic study of dipyridamole. Dipyridamole and internal standard, loxapine, were extracted from human serum by liquid-liquid extraction with diethyl ether and analyzed on a Nova Pak $C_{I8}$ column with the mobile phase of 40 mM ammonium acetate:methanol:acetonitrile (35:35:30)(v/v/v, pH 7.8). Detection wavelength of 280 nm and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^3$ factorial design using a fixed dipyridamole concentration (50 ng/mL) with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 2-2000 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 2 ng/mL, which was sensitive enough for pharmacokinetic studies of dipyridamole. The overall accuracy of the quality control samples ranged from 103.94 to 105.86% for dipyridamole with overall precision (% C.V.) being 4.60-11.49%. The relative mean recovery of dipyridamole for human serum was 97.64%. Stability studies showed that dipyridamole was stable during storage, or during the assay procedure in human serum. The peak area and retention time of dipyridamole were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of dipyridamole in human serum samples for the pharmacokinetic studies of orally administered Dimor tablet (75 mg as dipyridamole) at three different laboratories, demonstrating the suitability of the method.

Development and Validation of HPLC Method for Pharmacokinetic Study of Promethazine in Human (염산프로메타진 체내동태 연구를 위한 혈청 중 프로메타진의 HPLC 정량법 개발 및 검증)

  • Cho, Hae-Young;Kang, Hyun-Ah;Lee, Hwa-Jeong;Choi, Hoo-Kyun;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.36 no.1
    • /
    • pp.23-29
    • /
    • 2006
  • A rapid, selective and sensitive reversed-phase HPLC method for the determination of promethazine in human serum was developed, validated, and applied to the pharmacokinetic study of promethazine. Promethazine and internal standard, chlorpromazine, were extracted from human serum by liquid-liquid extraction with n-hexane containing 0.8% isopropanol and analyzed on a Capcell Pak CN column with the mobile phase of acetonitrile-0.2 M potassium dihydrogen phosphate (42:58, v/v, adjusted to pH 6.0 with 1 M NaOH). Detection wavelength of 251 nm and flow rate of 0.9 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed promethazine concentration (10 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 1-40 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was 1 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 96.15 to 105.40% for promethazine with overall precision (% C.V.) being 6.70-11.22%. The relative mean recovery of promethazine for human serum was 63.54%. Stability (freeze-thaw and short-term) studies showed that promethazine was stable during storage, or during the assay procedure in human serum. However, the storage at $-80^{\circ}C$ for 4 weeks showed that promethazine was not stable. Extracted serum sample and stock solution were not allowed to stand at ambient temperature for 12 hr prior to injection. The peak area and retention time of promethazine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of promethazine in human serum samples for the pharmacokinetic studies of orally administered Himazin tablet (25 mg as promethazine hydrochloride) at three different laboratories, demonstrating the suitability of the method.

Effect of Protease on the Morphological Properties and Dyeability of Human Hair (프로테아제 처리가 모발의 염색성 및 형태적 특성에 미치는 영향)

  • Kim, Hong-Hee;Kwon, Tae-Jong
    • Textile Coloration and Finishing
    • /
    • v.20 no.2
    • /
    • pp.59-65
    • /
    • 2008
  • The tannin acid and the enzymes have been used in order to improve the ruggedness in laundry and the absorption of dyes and pigments in the textile industry for several years. The enzyme processing on the protein fiber minimizes the damage of the entire fiber and improves the dyeability by effectively modifying only the hydrophobic surface. This study tried out the structural observation by applying the Castanea crenata sieb. et. zucc. containing abundant tannin to the hair dyeing as the natural dyeing pigment along with Protease of Rhizopus sp. The dyeability was improved as compared to the dyeing using only the synthetic tanning and iron mordant. When the depth of pigment was higher in accordance with the surface observation, the enzyme dissolution had impact on dyeing and so the keratin layer on the hair surface. Accordingly, it was found that the appropriate depth was between 0.01 and 0.03%. It was estimated that 0.1% protease would treated within 30min. Consequently, it would cause the good reaction with the functional group of tannin pigment.

Evaluation of Brand Personality by Advertising Message (광고 표현에 따른 브랜드 개성 평가)

  • Park, Pumsoon
    • The Journal of the Korea Contents Association
    • /
    • v.14 no.5
    • /
    • pp.55-62
    • /
    • 2014
  • This study investigated the brand personality of competitive brands in the same product category by conducting the evaluation of advertising message. The common personalities and different personalities of some brands were compared. The outdoor product was chosen for a product category. 4 different brands recently launched were selected for the study. For the analysis, every 3 TV commercials of each brand were examined by experiment respondents. As a result, all brands had two common brand personalities-passion and competence. Other representative brand personalities were ruggedness, sophistication, and sincerity.

A Study of objectification and observations on the morphology of meridian point (경혈반응점의 형태학적 관찰과 객과화에 관한 연구)

  • Shin, M.H.;Eo, Y.K.;Lee, H.H.;Lee, S.R.;Park, H.C.;Jeong, D.M.
    • Proceedings of the KOSOMBE Conference
    • /
    • v.1997 no.05
    • /
    • pp.309-312
    • /
    • 1997
  • Meridian collteral and meridian points have been he base of acupunurre therapy. Also the theory have composed the main portion of oriental medicine. But the mechanism and scientific backgroud has not been completely eastablished, and the research on the objectification of diagonosis of meridian collateral and meridian points, and acupuncture therapy has been necessary nowday. A new understanding of value of oriental medicine has been increasing, the scientific understanding of meridian collateral and meridian points should have been examined. In this paper, we observed meridian point on the morphology for objectification and meridian visulalization we try to meridian point to use methylene blue and optical equipment of high power magnifications. The result of this study suggest that we can observe ruggedness part on body surface to be estimated meridian point. It is observed to have similarity each time of different meridian points. Also, we can observe part alteration of meridian points each time which observed to use method of electronic resistance of unsimilarity on the morphology.

  • PDF

Prediction of Wind Shear Exponent in Complex Terrain (복잡지형에서의 Wind Shear Exponent 예측)

  • Kim, Hyeon-Gi;Kim, Byeong-Min;Kim, Jin-Han;Paek, In-Su;Yoo, Neung-Soo
    • Journal of the Korean Solar Energy Society
    • /
    • v.32 no.2
    • /
    • pp.87-94
    • /
    • 2012
  • In this study, we found a relationship between wind shear exponent, ${\alpha}$, and a few factors such as the wind speed, $V$, ruggedness index($RIX$), and the Weibull shape parameter, $k$ of sites in complex terrain in Korea. Wind shear exponents in main wind directions were calculated using wind speed data measured for one year from various heights of eleven meteorological masts in Gangwon province. It was found from the analysis that the reciprocal of the wind shear exponent can be expressed by an exponentially decaying function with respect to a multiple of $V$, $RIX$ and $k$. This result is considered useful to be used to characterize wind characteristics of specific sites in complex terrain in Korea with limited information.

Influence of Artificial Defect on Fatigue Limit in Austempered Ductile Iron (오스템퍼링처리한 구상흑연주철의 피로한도에 미치는 인공결함의 영향)

  • Kim, Min-Geon;Kim, Jin-Hak
    • Transactions of the Korean Society of Mechanical Engineers A
    • /
    • v.23 no.11 s.170
    • /
    • pp.1922-1928
    • /
    • 1999
  • Rotary bending fatigue tests were carried out to investigate the influence of artificial defects on fatigue limit in annealed and austempered ductile iron. Obtained main results are as follows : (1) Artificial defect(micro hole type, dia.<0.4 mm) on specimen surface did not bring about a obvious reduction of fatigue limit in austempered ductile iron(ADI) as compared with annealed ductile iron. (2) According to the investigation of $\sqrt{area}_c$ which is the critical defect size to crack initiation at artificial defect, $\sqrt{area}_c$ of ADI is larger than that of annealed ductile iron. This shows that the situation of crack initiation at artificial defect in ADI is more difficult in comparison with annealed ductile iron. (3) One of the reasons for the low rate of crack initiation from artificial defect in ADI is that the resistance of matrix to crack initiation is higher than that of annealed ductile iron. (4) In case that the $\sqrt{area}$ of artificial defect and graphite nodule is the same, the rate of crack initiation from graphite nodule is higher than that from artificial defect. This reason is that the serious ruggedness around graphite nodule is formed by austempering treatment.